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Trial registered on ANZCTR


Registration number
ACTRN12618000224224
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
12/02/2018
Date last updated
21/02/2020
Date data sharing statement initially provided
21/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Benefits of Education and Exercise Therapy for people with knee cap pain: BEEP Trial.
Scientific title
Benefits of Education and Exercise Therapy delivered by Physiotherapists for people with patellofemoral pain (BEEP): Pilot Randomised Controlled Trial.
Secondary ID [1] 292893 0
Nil known
Universal Trial Number (UTN)
U1111-1202-2101
Trial acronym
BEEP Trial
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral Pain 304739 0
Condition category
Condition code
Musculoskeletal 304064 304064 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 305558 305558 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be divided in 2 phases:

For phase 1 and 2 participants will be asked to: avoid taking antiinflamatory or analgesic medications; avoid participating in any additional physiotherapy program; avoid making any drastically changes in their diet. Participants will be asked to report any of these events in their paper diary.

Phase 1 will involve a 6 week period of self-directed education using a purposely created online platform and printed leaflets.

- Self-directed education:
A physiotherapist (> 5 years' experience) will introduce the content of the website and leaflet for each participant in a 30-minutes session. The website was designed to educate patients with patellofemoral pain how to manage their knee pain by themselves based on the best evidence available. It will consist in 3 main topics:
1 - Understanding patellofemoral pain
- Why does it hurt?
- Diagnosis
- How common is patellofemoral pain?
- What pain is ok?
- When will my pain stop?
- Fear of movement
- Manage your load to manage your pain.

2 - Treatment options
- What works?
- Exercise
- Taping/Bracing
- Orthotics
- Other options?
- Surgery
- PRP
- Ultrasound

3 - Exercise program
- Exercise 1 - Bridges
- Exercise 2 - Core
- Exercise 3 - Hip
- Exercise 4 - Squats


In addition to the website, we will deliver an education leaflet titled "Managing my patellofemoral pain", which was previous published, also freely available for general public "Barton CJ, Rathleff MS ‘Managing My Patellofemoral Pain’: the creation of an education leaflet for patients BMJ Open Sport & Exercise Medicine 2016;2:e000086. doi: 10.1136/bmjsem-2015-000086"

Following this 6 week period, participants who do not consider themselves completely recovered will enter into phase 2: a double blind two arm pilot randomised trial conforming to CONSORT guidelines involving different physiotherapist led exercise and education interventions, provided over 12 weeks. The mode of administration of both interventions will be one-on-one (participant and physiotherapist).

The tested intervention will be a Physiotherapist-delivered exercise program.
- Physiotherapist-delivered exercise group
One physiotherapist (5 years' experience) will deliver a 12-weeks exercise program to the participants of this randomised controlled trial.
Participants will attend to 8 sessions in a Physiotherapy Clinic which will be distributed according to the topics below:
- Week 1: 1-hour session
- Week 2: 1-hour session
- Week 3: 1-hour session
- Week 4: 1-hour session
- Week 6: 1-hour session
- Week 8: 1-hour session
- Week 10: 1-hour session
- Week 12: 1-hour session

Besides the sessions with the physiotherapist, participants will be instructed to perform the exercises 2 times a week at home.

The adherence to the recommended home-based exercises and physiotherapy sessions will be assessed through the app "Physio Track", available at: http://www.physiotrack.co.uk/our-app/ or paper diary depending on preference

The intervention and recommendations will consist in progressive core, hip and knee strengthening exercises, gait retraining in gestures participants report knee pain and gradual exposure to pain exacerbating activities.
Intervention code [1] 299134 0
Rehabilitation
Comparator / control treatment
The comparator group will be a Physiotherapist-delivered Education.
- Physiotherapist-delivered Education group
One physiotherapist (5 years' experience) will deliver 12-weeks education program to the participants of this randomised controlled trial.

Participants will attend to 8 sessions via Skype to receive education about how to perform exercise and manage loads based on the material freely available on the website

Sessions will be distributed according to the topics below:
- Week 1: 1-hour session
- Week 2: 1-hour session
- Week 3: 1-hour session
- Week 4: 1-hour session
- Week 6: 1-hour session
- Week 8: 1-hour session
- Week 10: 1-hour session
- Week 12: 1-hour session

Besides the Skype sessions with the physiotherapist, participants will be instructed to perform the exercises 2 times a week at home.

The exercises instructions which will be given via Skype will be the same as those received by the Physiotherapist-delivered exercise group. The physiotherapist will advise participants via Skype to perform progressive core, hip and knee strengthening exercises, instructions about gait retraining in gestures participants report knee pain and gradual exposure to pain exacerbating activities.

The adherence to the recommended home-based exercises and Skype sessions will be assessed through the app "Physio Track", available at: http://www.physiotrack.co.uk/our-app/ or paper diary depending on preference.
Control group
Active

Outcomes
Primary outcome [1] 303411 0
Worst knee pain in the previous week (Visual Analogue Scale 0 - 100mm)
Timepoint [1] 303411 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Primary outcome [2] 303415 0
Global rating scale of recovery (6-itens Likert scale)
1 – Marked worsening.
2 – Moderate worsening.
3 – Same.
4 – Moderate improvement.
5 – Marked improvement.
6 – Completely recovered.
Timepoint [2] 303415 0
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [1] 338863 0
Kinesiophobia (TAMPA scale)
Timepoint [1] 338863 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [2] 338864 0
Quality of Life (KOOS quality of life subscale)
Timepoint [2] 338864 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [3] 338867 0
Catastrophism (Pain Catastrophism Scale)
Timepoint [3] 338867 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [4] 338872 0
Self-efficacy (Knee self-efficacy scale)
Timepoint [4] 338872 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [5] 342503 0
Digital literacy (Internet-literate tool). This tool was designed specifically for this study.
Timepoint [5] 342503 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [6] 342504 0
Knee-related self-confidence (Question 3 of the KOOS - subscale quality of life)
Timepoint [6] 342504 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [7] 342505 0
Knowledge about patellofemoral pain (Pain CAT Knowledge Questionnaire. A questionnaire developed to assess participant’s knowledge about what Cause And possible Treatments for their knee pain). This tool was designed specifically for this study.
Timepoint [7] 342505 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [8] 342776 0
Pressure pain threshold (Center of patella)
Timepoint [8] 342776 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [9] 342777 0
Pressure pain threshold (tibialis anterior)
Timepoint [9] 342777 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [10] 342778 0
Pressure pain threshold (elbow)
Timepoint [10] 342778 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [11] 342782 0
Single leg hop test (cm)

Description: The participants will be positioned with the heel in a marking on the floor and will be instructed to stand in unipodal support. Then, the participants will hop forward with their test leg as far as possible landing on the same foot. During this movement, the arms will not be allowed to swing. The distance of the jump will be measured in centimeters at the heel position from which the participant landed. In addition, the hop will be validated only if the participant is be able to maintain their balance upon landing, keeping their landing foot on the ground, without performing extra leaps, until the examiner marking where the participant landed. The test will be performed three times and we will consider the average of these 3 times. If the hop is not validated, the participants will be asked to repeat the task.
Timepoint [11] 342782 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [12] 342783 0
Forward step-down test (repetitions)

Description: Participants will be asked to stand on a 20.32cm high platform in a bipodal stance and step forward to tap with their non-test leg on the ground in front of the step, while keeping the tested leg on the step, before returning to starting position. The number of repetitions that the participant perform in 30 seconds will be recorded, and for the repetition to be validated, the participant should touch the floor with only the heel, returning the position of complete extension of the knee without impelling.
Timepoint [12] 342783 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [13] 342792 0
Forward step-down test (quality of movement)

Description: Participants will be asked to stand on a 20.32cm high platform in a bipodal stance and step forward to tap with their non-test leg on the ground in front of the step, while keeping the tested leg on the step, before returning to starting position. After 5 consecutive trials is completed, an examiner will rate the performance of the participants across all 5 repetitions of the forward step=down. Standing 3 m directly in front of and facing the participant, the examiner will score the test, based on the following 5 criteria:
1. Arm strategy: if the participant uses an arm strategy to recover balance, 1 point will be given. Because participants will be instructed to keep their hands on their waist, removing their hands from their waist will be interpreted as a strategy to
recover balance.
2. Trunk movement: if the participant leans the trunk to either side, interpreted as recovering balance, 1 point will be given.
3. Pelvic plane: if 1 side of the pelvis rotates in the transverse plane or elevated in the frontal plane compared with the other side, 1 point will be given.
4. Knee position: if the knee of the tested limb moves medially in the frontal plane and the tibial tuberosity crosses an imaginary vertical line positioned directly over the second toe of the tested foot, 1 point will be given. If the knee moves medially and the tibial tuberosity crosses an imaginary vertical line positioned directly over the medial border of the tested foot, 2 points will be given.
5. Maintenance of a steady unilateral stance: if the participants has to support body weight on the nontested limb, or the foot of the tested limb moves during testing, 1 point will be given.
Timepoint [13] 342792 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [14] 342793 0
Knee extensors strength (Handheld dynamometer)
Timepoint [14] 342793 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [15] 342794 0
Hip abductors strength (Handheld dynamometer)
Timepoint [15] 342794 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement
Secondary outcome [16] 342795 0
Hip extensors strength (Handheld dynamometer)
Timepoint [16] 342795 0
- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Eligibility
Key inclusion criteria
The following inclusion criteria will be applied by a licensed physical therapist (> 5 years of clinical experience): i) anterior knee pain during at least two of the following activities: stair ascent or descent, squatting, prolonged sitting, kneeling, running, and jumping; ii) symptoms for at least one month with an insidious onset; and iv) pain level of at least 20 mm on a 100 mm visual analogue scale in the previous week.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be events of patellar subluxation or dislocation, lower limb inflammatory process, lower limb surgery, patellar tendon or meniscus tears, bursitis, ligament tears, or the presence of neurological diseases. Individuals who had received oral steroids and opiate treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the RANDOM function of the software Microsoft Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation for the RCT was made based on the findings of Esculier et al. (1) who provided an education program to participants with patellofemoral pain. To detect a mean difference of 34 cm in a pain visual analogue scale (0 to 100 mm) after 8 weeks of education program, with a standard deviation of 3.55, a=0.05, power=80%, 13 participants are needed in each group. Expecting a withdrawal rate of 15%, we will recruit 30 participants, 15 for each group.
We will consider as a minimally clinical important difference 20 mm in a pain visual analogue scale (0 to 100 mm) according to Crossley et al (2).

For the phase 1 of this study a dependent t test will be performed to compare the baseline outcomes and the outcomes after a 6-weeks self-direct education program.

For the phase 2 the outcomes will be analyzed using a separate 2-by-3 (group-by-time) mixed model analyses of variance. The factor of group will have 2 levels (Physiotherapist-delivered Exercise group and Physiotherapist-delivered Education group) and the repeated factor of time will have 3 levels (baseline, 6 weeks and 18 weeks after intervention). An intention-to-treat analysis will be performed using the last value-carried-forward method to impute values for all missing data.

(1) Esculier J-F, Bouyer LJ, Dubois B, et al. Is combining gait retraining or an exercise programme with education better than education alone in treating runners with patellofemoral pain?A randomised clinical trial. Br J Sport Med. 2017:In Press. doi:10.1136/bjsports-2016-096988.

(2) K.M. Crossley, K.L. Bennell, S.M. Cowan, S. Green, Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch. Phys. Med. Rehabil. 85 (2004) 815–822.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/02/2018
Actual
1/02/2018
Date of last participant enrolment
Anticipated
19/04/2018
Actual
15/05/2018
Date of last data collection
Anticipated
14/12/2018
Actual
10/12/2018
Sample size
Target
30
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 17536 0
3000 - Melbourne
Recruitment postcode(s) [2] 17537 0
3072 - Preston
Recruitment postcode(s) [3] 17538 0
3083 - Bundoora
Recruitment postcode(s) [4] 17539 0
3083 - La Trobe University
Recruitment postcode(s) [5] 17540 0
3083 - Kingsbury
Recruitment postcode(s) [6] 17541 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 297525 0
University
Name [1] 297525 0
La Trobe University
Country [1] 297525 0
Australia
Primary sponsor type
Individual
Name
Christian John Barton
Address
La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC
Country
Australia
Secondary sponsor category [1] 296529 0
Individual
Name [1] 296529 0
Danilo de Oliveira Silva
Address [1] 296529 0
La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC
Country [1] 296529 0
Brazil
Other collaborator category [1] 279734 0
Individual
Name [1] 279734 0
Kay Crossley
Address [1] 279734 0
La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC
Country [1] 279734 0
Australia
Other collaborator category [2] 279735 0
Individual
Name [2] 279735 0
Fábio Mícolis de Azevedo
Address [2] 279735 0
University of Sao Paulo State. Roberto Simonsen Street, 305, 19060-900, Presidente Prudente-SP
Country [2] 279735 0
Brazil
Other collaborator category [3] 279921 0
Individual
Name [3] 279921 0
Marcella Ferraz Pazzinatto
Address [3] 279921 0
La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC
Country [3] 279921 0
Australia
Other collaborator category [4] 279922 0
Individual
Name [4] 279922 0
Ebonie Rio
Address [4] 279922 0
La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC
Country [4] 279922 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298621 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 298621 0
Ethics committee country [1] 298621 0
Australia
Date submitted for ethics approval [1] 298621 0
22/09/2017
Approval date [1] 298621 0
22/01/2018
Ethics approval number [1] 298621 0
HEC17-102

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77678 0
Dr Christian John Barton
Address 77678 0
La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC
Country 77678 0
Australia
Phone 77678 0
+61403012914
Fax 77678 0
Email 77678 0
[email protected]
Contact person for public queries
Name 77679 0
Christian John Barton
Address 77679 0
La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC
Country 77679 0
Australia
Phone 77679 0
+61403012914
Fax 77679 0
Email 77679 0
[email protected]
Contact person for scientific queries
Name 77680 0
Danilo de Oliveira Silva
Address 77680 0
La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC
Country 77680 0
Australia
Phone 77680 0
+61420629982
Fax 77680 0
Email 77680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any data collected by this study.
When will data be available (start and end dates)?
The data will be available from January 2019 up to January 2034.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
For IPD meta-analyses and other research purposes.
How or where can data be obtained?
The lead investigator Dr Christian Barton should be contacted.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7010Ethical approval    373655-(Uploaded-14-01-2020-13-29-39)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNovel stepped care approach to provide education and exercise therapy for patellofemoral pain: Feasibility study.2020https://dx.doi.org/10.2196/18584
N.B. These documents automatically identified may not have been verified by the study sponsor.